Doses of Xarelto, Eliquis or Pradaxa in ICU Often Inappropriate: Study

The findings of a new study suggest that about one-in-three patients given a new-generation blood thinner in an ICU, such as Xarelto, Pradaxa or Eliquis, may be receiving inappropriate dose, as doctors often fail to factor in potential kidney problems that could increase the risk of dangerous and uncontrollable bleeding problems. 

In a study presented at a meeting of the Society of Critical Care Medicine, researchers from Fairleigh Dickinson University School of Pharmacy in New Jersey found that seven out of 21 patients who were treated in an intensive care unit (ICU) were given the wrong dose of novel oral anticoagulants (NOACs).

The prescription errors in four of the patients occurred because doctors did not take into account problems with kidney function, one of whom suffered a bleeding event. Such renal impairments may limit the body’s ability to filter the blood thinners out over time, meaning that patients are at an increased risk of bleeding, which doctors may then be unable to stop or control, given the lack of approved reversal agents available for these new medications.

Unlike warfarin, which has been the go-to anticoagulant treatment for prevention of strokes among patients with atrial fibrillation for decades, there are no antidotes approved for Xarelto, Pradaxa or Elliquis, which may lead to more severe outcomes if bleeds develop. In addition, the impact of the inappropriate dosing may be compounded by the fact that manufacturers of the new blood thinners have promoted the drugs as not requiring blood monitoring, which means doctors may miss the fact that levels of the blood thinners in patients is high and placing them at higher risk of an uncontrollable bleeding event.

“Although NOACs do not require routine coagulation monitoring, there is lack of an antidote for reversal in bleeding patients and concerns in dosing of NOACs in renal impairment,” the researchers noted. “There is a lack of experience with use of NOACs in critically ill patients.”

Most of the patients in the study had nonvalvular atrial fibrillation, and the blood thinners were given to them as a means of stroke prevention. Others were given blood thinners to treat problems associated with blood clots. However, some health experts say that doctors can wait long enough to determine kidney function before prescribing the drugs without placing patients at significantly increased risk of stroke or other problems while they wait for test results.

The most commonly used blood thinner in the study was Xarelto, which was given to nine patients.

New Anticoagulant Bleeding Risks

Xarelto (rivaroxoaban) was the second member of this new generation of blood thinners introduced in 2011, but has become the most widely used of the novel drugs. Known as “Factor Xa” anticoagulants, which have been aggressively promoted the drugs as superior alternatives to warfarin, Pradaxa (dabigatran) was introduced in late 2010 and Elliquis (apixaban) was introduced in 2012.

While Coumadin (warfarin) is widely available as a generic and substantially less expensive than the new medication, the manufacturers have encouraged doctors to switch patients by suggesting that Xarelto and other members of this new class are safer and easier to use, without the need for blood monitoring during treatment. However, recent studies have raised concerns about those claims, suggesting that blood monitoring on Xarelto may actually reduce the risk of severe bleeding problems.

As the popularity of Xarelto has increased, concerns have emerged about the bleeding risk, as large numbers of patients and doctors have reported incidents of uncontrollable hemorrhaging or bleeds, that may result in severe injury or death.

While all blood thinners carry a risk of bleeding problems, doctors can quickly stop the blood thinning effects of warfarin. However, there is no Xarelto antidote, leaving physicians unable to stop bleeding problems that may occur during use, which may increase the risk of more severe injury or death.

Bayer and Janssen now face a growing number of Xarelto lawsuits, which allegations that the drug makers placed their desire for profits before the safety of consumers by aggressively marketing the drug without adequate warnings, and for failing to fully explore all potential reversal agents that may have made the medication safer. Many plaintiffs also allege that the benefits provided by the medication do not justify the risks, indicating that the drug makers should issue a Xarelto recall until a reversal agent can be developed.

Last month, a panel of federal judges ordered the centralization of all Xarelto bleeding lawsuits, transferring cases filed throughout the federal court system to one judge in Louisiana for coordinated pretrial proceedings.